Behavioral Exercise Training to Reduce Cardiovascular Disease Risk (EXTRA-PC)

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Supportive Care; Prostate Cancer

Treatments: Behavioral: Healthy Living Education; Behavioral: Exercise Training Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06237179

HM20028583 (Other Identifier)

1K01HL161419-01A1 (U.S. NIH Grant/Contract)

MCC-23-20934

Details and patient eligibility

About

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak & 6-minute walk distance [6MWD]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.

Enrollment: 60 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be diagnosed with stage II/III/IV prostate cancer
• Be currently undergoing treatment with ADT (intermittent or prolonged)
• Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
• Be >40 years of age up to 85;
• Be willing to sign an informed consent with HIPAA authorization form;
• Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
• Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
• Be without any serious medical condition that precludes safe participation in an exercise program;
• Speak English

Exclusion criteria

• Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
• Have contraindications to exercise testing;
• Have pre-existing overt cardiovascular disease/heart failure;
• Active illness/infection;
• Hemoglobin < 7.0 grams/dL
• Platelet count < 10 x 109/L

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Exercise Training Intervention

Experimental group

Description:

The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity

Treatment:

Behavioral: Exercise Training Intervention

Healthy Living Education Control

Active Comparator group

Description:

Educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.

Treatment:

Behavioral: Healthy Living Education